Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________ FORM 10-Q _______________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ____ ...

The market expects Ovid Therapeutics (OVID) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if t ...

NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company dedicated to developing medicines for brain conditions with significant unmet need, today announced that Meg Alexander, President and Chief Operating Officer, will present at the 24th Annual Needham Virtual Healthcare Conference on Monday, April 7, 2025, at 8:45 AM. ET. A live webcast of the Needham Virtual Healthcare Conference presentation can be accessed through the Events & Presentations secti ...

Ovid Therapeutics (OVID) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.16. This compares to loss of $0.22 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 18.75%. A quarter ago, it was expected that this company would post a loss of $0.19 per share when it actually produced a loss of $0.20, delivering a surprise of -5.26%.Over the last four quarters, the company has surpas ...

Financial Position - The company has sufficient cash on hand to fund operations into the second half of 2026[52]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $53.1 million[412]. - The company’s primary exposure to market risk is interest rate sensitivity, which is influenced by changes in U.S. interest rates[412]. - An immediate 100 basis point change in interest rates would not materially affect the fair market value of the company's cash equivalents and marketable securities[412]. - The company intends to maintain its portfolio of cash equivalents and marketable securities in institutional market funds, including U.S. Treasury and high-quality short-term corporate bonds[412]. Drug Development and Pipeline - OV329, a next-generation GABA-AT inhibitor, is being developed for adult and pediatric drug-resistant epilepsies and is shown to be 100-fold more potent than vigabatrin (VGB)[56][57]. - OV329 has demonstrated acceptable tolerability in humans with no serious adverse events reported during the Phase 1 study[62]. - The Phase 1 trial of OV329 is ongoing, with topline data expected in Q3 2025, and initial biomarker data suggests encouraging signs of target engagement[70][71]. - The company has in-licensed a portfolio of over 100 KCC2 direct activators from AstraZeneca, with plans to progress four unique programs into human clinical studies[72]. - OV329's preclinical studies indicate it does not accumulate in ocular tissues, unlike VGB, which is associated with ocular toxicity[64][68]. - The drug development strategy includes pursuing rare, resistant conditions as initial indications to demonstrate rapid proof-of-concept[52]. - The company employs biomarker strategies early in development to assess target engagement and pharmacodynamic effects[52]. - OV329's mechanism of action involves increasing GABA concentrations by inhibiting GABA-AT, potentially reducing seizures in patients[58]. - The KCC2 portfolio includes four programs in active development, targeting epilepsy and other neurological conditions, with potential therapeutic properties for anti-psychosis, anxiolytic, and anticonvulsant responses[75]. - OV350 IV initiated first-in-human studies in Q1 2025, with topline results expected in Q4 2025, focusing on safety, tolerability, and exploratory biomarkers[77]. - The company anticipates annual regulatory submissions for human trials from the KCC2 portfolio over the next three to four years, with a pending composition-of-matter application expiring in 2041[76]. - A collaboration with Graviton Bioscience Corporation was established in May 2023, involving a $10 million investment to develop OV888 (GV101), a selective ROCK2 inhibitor for rare neurological conditions[80][84]. - OV888 is currently on pause pending regulatory feedback on a competitive clinical-stage program for cerebral cavernous malformation (CCM), which affects approximately 1 in 250 individuals[82]. - The company has invested $5.1 million in Gensaic, Inc. to develop genetic medicines for neurological indications, retaining commercial rights to any resulting therapies[87]. - An exclusive license agreement with AstraZeneca was signed in December 2021, granting worldwide rights to KCC2 transporter activators for an upfront payment of $5 million and $7.3 million in stock[91]. Regulatory Environment - The FDA's review process for New Drug Applications (NDAs) typically takes about 10 to 12 months from submission, with a preliminary review occurring within the first 60 days[120][121]. - The FDA may require a risk evaluation and mitigation strategy (REMS) plan for drug approval, which could include various risk minimization tools[123]. - The company must comply with substantial regulatory requirements imposed by the FDA and other authorities throughout the drug development process[113][114]. - The FDA may impose post-approval requirements, including Phase 4 clinical trials and surveillance to monitor product safety and effectiveness after commercialization[131]. - Orphan Drug Act allows for orphan designation for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S., providing benefits like PDUFA fee waivers[128]. - Orphan drug exclusivity grants seven years of market exclusivity post-approval, preventing other applications for the same indication unless clinical superiority is demonstrated[129]. Market and Competitive Landscape - The field of epilepsy and psychiatric medicines is highly fragmented, with competitors including UCB, Jazz Pharmaceuticals, and Acadia Pharmaceuticals, among others[100]. - The company faces significant competition in drug development, with competitors having greater financial and technical resources, as well as more experience in obtaining regulatory approvals[101]. - The company may face challenges in obtaining regulatory approval and achieving market acceptance due to the competitive landscape and potential advancements by competitors[103]. - Sales of drug candidates depend on coverage by third-party payors, which are increasingly limiting coverage and reducing reimbursements[136]. - The Affordable Care Act has significantly impacted the pharmaceutical industry, including establishing fees for manufacturers and revising Medicaid rebate calculations[142]. - The Inflation Reduction Act allows HHS to negotiate prices for certain high-expenditure drugs, affecting future revenue potential[145]. Human Capital and Corporate Governance - As of December 31, 2024, the company had 23 full-time employees, primarily in research and development, including professionals with extensive neurology experience[146]. - The company emphasizes employee engagement, talent acquisition, and diversity in managing human capital assets[147]. - The company has implemented hybrid work policies since 2022, enhancing employee work environment[152]. - The Board of Directors consists of five members, with four being independent, providing diverse expertise for company performance and growth[151]. - The company has equity incentive plans aimed at attracting and retaining top talent through equity-based and cash-based compensation awards[150]. - The company emphasizes a diverse and inclusive culture to attract and retain top talent necessary for growth[148]. Intellectual Property - The company has licensed a portfolio of U.S. and international patents related to its drug candidates, including OV101, OV329, and OV888, with expiration dates ranging from 2036 to 2041[106][107][108]. - The company relies on trade secrets and confidentiality agreements to protect its proprietary information, but there is a risk of breaches or independent discovery by competitors[111]. - The company has a library of proprietary genetic sequences targeting various disorders, which is part of its expanding intellectual property portfolio[109]. - The company has filed multiple patent families directed to methods of treatment and formulations, enhancing its competitive position in the market[106][108]. Compliance and Risk Management - Compliance with healthcare regulations is critical, as violations can lead to significant penalties, including exclusion from federal healthcare programs[140]. - Future healthcare reforms may result in lower reimbursements and impact revenue from product sales[141].

Stelios Papadopolous, Ph.D., a pioneering leader in biotech, appointed to Board of Directors; two industry veterans joined management team as Ovid prepares to take OV329 into patient trials and move its first KCC2 direct activator into the clinicTopline results from Phase 1 study of OV329 expected in Q3 2025, which will include biomarkers that measure clinical effect and target engagement, safety, and tolerabilityOV350, Ovid’s first program in its KCC2 direct activator library, initiated a first-in-human st ...

Core Viewpoint - Ovid Therapeutics Inc. has appointed Dr. Stelios Papadopoulos to its Board of Directors, which is seen as a strategic move to enhance the company's growth and innovation in developing small-molecule medicines for neurological and psychiatric conditions [1][2]. Company Overview - Ovid Therapeutics is a biopharmaceutical company focused on creating novel medicines for brain conditions with significant unmet needs, advancing a pipeline of targeted small molecule candidates [4]. - The company is developing several key programs, including OV329 for treatment-resistant seizures, OV350 targeting multiple CNS disorders, and OV888/GV101 for neurovascular and neuro-inflammatory conditions [4]. Leadership and Expertise - Dr. Stelios Papadopoulos is recognized as a pioneering force in biotechnology, with over four decades of experience, including roles in investment banking and equity research [2]. - His leadership and strategic vision are expected to be instrumental in propelling Ovid forward, particularly in the context of its advancing pipeline and the potential for transformative medicines [2][3]. Strategic Importance - The appointment of Dr. Papadopoulos comes at a critical time for Ovid, as the company aims to deliver significant advancements in the treatment of neurological and psychiatric diseases [2]. - His involvement is anticipated to enhance Ovid's capabilities in bridging scientific discovery with financial strategy, which is crucial for the company's growth [2].

Company Overview - Ovid Therapeutics Inc. is a biopharmaceutical company based in New York, focused on developing medicines for brain conditions with significant unmet needs [3] - The company is advancing a pipeline of novel, targeted small molecule candidates aimed at modulating factors involved in neuronal hyperexcitability, which is linked to various neurological and neuropsychiatric disorders [3] Pipeline Development - Ovid is developing several key candidates, including: - OV329, a next-generation GABA-aminotransferase inhibitor, targeting treatment-resistant seizures and other undisclosed indications [3] - OV350, along with a library of compounds that activate the KCC2 transporter, aimed at multiple CNS disorders [3] - OV888/GV101, a highly selective ROCK2 inhibitor, for undisclosed neurovascular and neuro-inflammatory conditions [3] Upcoming Events - Meg Alexander, President and Chief Operating Officer of Ovid Therapeutics, will present at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, at 3:10 p.m. ET in Boston, Massachusetts [1] - A live webcast of the presentation will be available on the company's website, with an archived replay accessible for approximately 30 days post-event [2]

NEW YORK, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company dedicated to developing medicines for brain conditions with significant unmet need, today announced that management will participate in a virtual presentation at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, February 12, 2025, at 4:00 p.m. ET. A live webcast of the presentation can be accessed through the Events & Presentations section of the Company's website at inve ...

Company Performance - Ovid Therapeutics reported a quarterly loss of $0.20 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.19, and compared to a loss of $0.16 per share a year ago, indicating a negative earnings surprise of -5.26% [1] - The company posted revenues of $0.17 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 15.33%, and showing an increase from $0.11 million in the same quarter last year [2] - Over the last four quarters, Ovid Therapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Performance - Ovid Therapeutics shares have declined approximately 57.8% since the beginning of the year, contrasting with the S&P 500's gain of 25.8% [3] - The current Zacks Rank for Ovid Therapeutics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $0.16 million, and for the current fiscal year, it is -$0.49 on revenues of $0.56 million [7] - The estimate revisions trend for Ovid Therapeutics is mixed, and changes in earnings expectations may occur following the recent earnings report [6] Industry Context - Ovid Therapeutics operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]